Recon: Senate passes major drug pricing reforms; Pfizer to buy Global Blood Therapeutics for $5.4B

ReconRecon | 08 August 2022 | By

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Analysis: Democrats score big wins on climate, drugs with $430 billion U.S. Senate bill (Reuters) (Endpoints) (Pink Sheet) (STAT)
  • White House worked behind the scenes to push Senate toward breakthrough win (The Hill)
  • Democrats dramatically narrow their ambitions for lowering insulin costs (STAT)
  • Enhertu Goes Into High Gear With HER2-Low Breast Cancer Approval (Scrip) (Reuters)  (MedPage Today)
  • Pfizer and Myovant’s endometriosis pain drug Myfembree gets an FDA nod (Endpoints)
  • FDA declines to approve expanded use of Acadia's antipsychotic drug (Reuters)
  • FDA’s RTOR Program Produces Approvals About One Month Sooner Than Priority Review Goal (The Pink Sheet)
  • Abortion bans complicate access to drugs for cancer, arthritis, even ulcers (Washington Post)
  • There’s Just One Drug to Treat Monkeypox. Good Luck Getting It. (NYT)
In Focus: International
  • Plans Press On To Harmonize Decentralized Clinical Trial Requirements In EU (The Pink Sheet)
  • UK Retiring eSUSAR Portal For Reporting Clinical Trial Safety Issues (The Pink Sheet)
  • Sanofi increases China oncology focus with Innovent partnership (Biopharma Reporter)
  • What’s in, what’s out in R&D for U.S.-India stakeholders (BioCentury)
  • BioNTech expects Omicron-adapted vaccine deliveries as soon as October (Reuters)
  • BioNTech Sinks as Covid Vaccine Sales and Profit Disappoint (Bloomberg)
Pharma & Biotech
  • Pfizer Doubles Down on Sickle Cell Disease with $5.4B Global Blood Therapeutics Buy (Biospace) (Bloomberg) (Fierce) (STAT)
  • Reata continues to hit FDA roadblocks with its Friedreich’s ataxia candidate, noting regulator 'concerns' (Endpoints)
  • Karuna’s resurrection of Lilly drug delivers phase 3 schizophrenia success, teeing up 2023 filing (Fierce) (Endpoints) (STAT)
  • Eli Lilly eyes growth outside Indiana in wake of new abortion law — and New Jersey is ready (Endpoints)
  • Amgen takes BiTEs out of pipeline, dropping BCMA, PSMA assets in light of data and competition (Fierce)
  • Serious liver side effects detour Amgen’s effort to expand use of its KRAS-blocking lung cancer drug (STAT) (Reuters)
  • Novo Touts Diabetes R&D As Ozempic Faces Lilly Challenger (Scrip)
  • At pioneering center for gene therapy, Jim Wilson presided over toxic, abusive workplace, staffers say (STAT)
Medtech
  • FDA’s breakthrough device designations poised for another record year (MedTech Dive)
  • FDA clears AI software for spotting prostate cancer in MRI scans (Fierce)
  • FDA clears Viz.ai’s algorithm to spot internal bleeds in brain scans (Fierce)
  • Medtech Multinationals Up Pace Of Localization Strategies In China (MedTech Insight)
  • MIT engineers develop shape-shifting artificial pancreas that brushes off the immune system’s rejection (Fierce)
  • Dentsply Sirona continues internal investigation into financial reporting practices (Fierce)
Government, Regulatory & Legal
  • AstraZeneca, Bristol Myers Squibb and McKesson Diabetes Drug Case Dismissed (FDAnews)
  • Landmark Opioid Opinion ‘Not Persuasive,’ W.VA. Panel Says (Law360)
  • Teva Gets Knocked Down, But it Gets Up Again—and Petitions SCOTUS (FDA Law Blog)
  • Roche Settles Claim Over NHS Over Procurement Process (Law360)
  • Eli Lilly Says Indian Abortion Law Forces Hiring Out-of-State (Bloomberg)
  • Healthineers Covid Test Profits Safe as Cellex Drops Patent Suit (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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